One-Year Postmarket Data Presented for Edwards Sapien Transcatheter Heart Valve

May 25, 2010—Edwards Lifesciences (Irvine, CA) announced that Martyn Thomas, MD, presented 1-year data from the company's SOURCE registry at the EuroPCR 2010 conference in Paris. Dr. Thomas reported that the Edwards Sapien transcatheter heart valve demonstrated promising 1-year mortality rates for high-risk patients, many of whom were too sick to undergo open heart surgery. At 1-year, there was an 81.1% survival rate in transfemoral procedures and a 72.1% survival rate in transapical procedures.

According to the company, the 1,038-patient SOURCE registry includes 1-year adjudicated data on consecutive patients treated with transcatheter heart valves with either a transfemoral or transapical approach. The registry includes outcome data from 100% of patients treated with the Edwards Sapien transcatheter heart valve at 32 European centers from November 2007 to January 2009 in its initial Cohort 1. One-year follow-up data were obtained for 98% of studied patients. Dr. Thomas also announced that 30-day results on an additional cohort of 1,301 patients (Cohort 2) that were enrolled in 2009 will be reported in the fall.

“The encouraging outcomes add to the evolving body of clinical evidence that demonstrates that transcatheter aortic valve implantation is a viable option for this high-risk patient population,” commented Dr. Thomas. “The data provide valuable, real-world insights that enable the continued advancement of this important treatment for patients in need of alternative therapies to traditional open heart surgery.” 



Olaf Wendler, MD, added, “The SOURCE registry is unprecedented in its rigor as a commercial registry, which is critical for our understanding of the developing therapy of transcatheter aortic valve implantation. The 1-year outcomes continue to demonstrate that European clinical teams are translating early clinical learnings into successful therapy in an appropriate patient population.”